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Balloon vs stent: new hope for heart patients without permanent metal?

NCT ID NCT04893291

Ongoing Disease control Sponsor: Fondazione Ricerca e Innovazione Cardiovascolare ETS Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a sirolimus-coated balloon works as well as a standard drug-eluting stent for opening narrowed heart arteries. About 1,820 adults with coronary artery disease will be randomly assigned to receive either the balloon or the stent during a routine angioplasty procedure. The main goal is to see if the balloon is non-inferior to the stent in preventing artery failure at one year.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
Sirolimus-coated balloon (Magic Touch) and everolimus-eluting stent
What this could lead to
If successful, this could offer a stent-free option for opening blocked heart arteries, potentially reducing long-term complications from permanent implants.
What could go wrong
This is a large but early-stage comparison; the balloon may not be as effective as the standard stent, and risks like artery re-narrowing or bleeding remain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder coronary stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CORONARY ARTERY DISEASE CORONARY ARTERY STENOSIS

Contacts and locations

Locations

  • 1st Military Institute of Medicine

    Lublin, Poland

  • A.R.N.A.S. Ospedali Civico Di Cristina Benfratelli

    Palermo, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, Italy

  • Albert Schweitzer Hospital

    Dordrecht, Netherlands

  • Altnagelvin Area Hospital

    Londonderry, United Kingdom

  • Azienda Ospedaliera "Ospedali Riuniti Villa Sofia-Cervello"

    Palermo, Italy

  • Azienda Ospedaliera Universitaria Integrata

    Verona, Italy

  • Azienda Ospedaliero-Universitaria Sant'Andrea

    Roma, Italy

  • Bangladesh Specialized Hospital Lt

    Dhaka, Bangladesh

  • Centre Hospitalier de SaintMalo

    St-Malo, France

  • Clinica Polispecialistica San Carlo

    Paderno Dugnano, 20037, Italy

  • Clinique Louis Pasteur

    Essey-lès-Nancy, France

  • Clinique Saint-Hilaire

    Rouen, France

  • Erasmus University Medical Center

    Rotterdam, Netherlands

  • Fondazione Poliambulanza

    Brescia, 25124, Italy

  • Golden Jubilee National Hospital

    Clydebank, United Kingdom

  • Groupe Hospitalier de La Rochelle

    La Rochelle, France

  • Haga Hospital Els Borst

    The Hague, Netherlands

  • Heliodors Święcicki Clinical Univeristy Hospital, Ul

    Poznan, Poland

  • Hospital Alvaro Cunqueiro-University Hospital of Vigo

    Vigo, Spain

  • Hospital General Universitario de Ciudad Real (HGUCR)

    Ciudad Real, Spain

  • Hospital Queen Elizabeth II

    Kota Kinabalu, Malaysia

  • Hospital Santa Isabel R. Frei Cornélio

    Ubá, Brazil

  • Hospital Universitario La Paz

    Madrid, Spain

  • Hospital Universitario Lucus Augusti (HULA)

    Lugo, Spain

  • Hospital Universitario Marqués de Valdecilla (HUMV)

    Santander, Spain

  • Hospital Universitario de Araba

    Vitoria-Gasteiz, Spain

  • Hospital Universitario y Politécnico La Fe

    Valencia, Spain

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Brazil

  • Hospital de La Princesa

    Madrid, Spain

  • Hôpital Prive du Confluent, 4 Rue Éric Tabarly

    Nantes, France

  • INC (National Institute of Cardiology),

    Rio de Janeiro, Brazil

  • InCor (Heart Institute)

    São Paulo, Brazil

  • Institute Dante Pazzanese of Cardiology

    São Paulo, Brazil

  • Istituto clinico Sant'Ambrogio

    Milan, Italy

  • Jurong Park Medical Centre JPMC

    Bandar Seri Begawan, Brunei

  • Kurmitola General Hospital

    Dhaka, Bangladesh

  • LABAID Cardiac Hospital

    Dhaka, Bangladesh

  • Les Hôpitaux de Chartres, Hôpital Louis Pasteur

    Le Coudray, France

  • Maasstad Hospital

    Rotterdam, Netherlands

  • National Heart Foundation Hospital & Research Institute

    Dhaka, Bangladesh

  • National Institute of Cardiovascular Disease

    Dhaka, Bangladesh

  • OLVG Onze Lieve Vrouwe Gasthuis location East

    Amsterdam, Netherlands

  • Ospedale Civile Sant'Andrea

    La Spezia, Italy

  • Ospedale Policlinico San Martino

    Genova, Italy

  • Ospedale S. Antonio Abate

    Trapani, Italy

  • Ospedale San Giuseppe Moscati

    Aversa, Italy

  • Ospedale Sandro Pertini

    Roma, 00157, Italy

  • Policlinico Tor Vergata

    Roma, Italy

  • Ramathibodi Hospital, Mahidol University

    Bangkok, Thailand

  • St Bartholomew's Hospital

    London, United Kingdom

  • University Hospitals Birmingham

    Birmingham, United Kingdom

  • University Malaya Medical Centre (Teaching and Research Hospital)

    Kuala Lumpur, Malaysia

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